紫雲膏とヒルドイドソフト軟膏の混合軟膏の外観変化による安定性の評価と配合変化に関する考察

Drug therapy with steroids and moisturizers is highly effective for the treatment of atopic dermatitis, but the use of steroids is dependent on the stage of the patient’s disease. Shiunkou is a Kampo topical ointment with a purple tinge called shicon. It has been reported to be used clinically in combination with a moisturizer; however its stability has not been described. In this study, we investigated the stability of Shiunkou and Hirudoid Soft Ointment when mixed. The simplest method for measuring stability is to observe changes in appearance. The mixed ointment did not change during refrigerated storage for up to 7 months. When stored at room temperature, oil separation occurred after the first month, and became more remarkable with time, such as at 3 months and 7 months. It has been shown that the ointment mixture should be stored refrigerated rather than stored at room temperature. When the stability of shicon, which is an active ingredient of Shiunkou, was examined in an aqueous solution, it decomposed very quickly regardless of the pH. Hirudoid Soft Ointment is a w/o preparation and contains water. When the ointment is mixed, and shicon, a the component of Shiunkou, comes into contact with the water contained in the Hirudoid Soft Ointment, there is a concern that the content of shicon in the ointment mixture may decrease, even if by a small amount or for a short time.論

医療用・一般用漢方製剤の情報の比較検討：葛根湯

[Purpose] Kampo medicine is widely used in Japan. Although traditional Kampo medicines were used through the decoction and combination of constituent crude drugs, powdered preparations such as extract granules are often used for the sake of simplicity. Kakkonto is a decoction made of seven kinds of crude drugs, including Kakkon. Many Kakkonto preparations exist for both prescription drugs and over-the-counter (OTC) drugs in Japan and are often prescribed by doctors. Furthermore, Kakkonto is well-known by citizens and used frequently as a general purpose medicine. Therefore, in this research, we aimed to compare prescription contents and formulations of Kakkonto in prescription and OTC drugs existing in Japan and identify differences.[Method] We searched for “Kakkonto” on the website of the Pharmaceuticals and Medical Devices Agency and obtained a package insert.[Result] As a result of our search of “Kakkonto,” we found 14 and 127 items for prescription and OTC drugs, respectively. For prescription drugs, 11 items were one of four prescriptions prescribed in the Japanese Pharmacopoeia, and the other item referred to Keishi instead of Keihi. The dosage was one time for all items. For OTC drugs, everything was one of the four prescriptions, but the dosage was 1/3 to 1 times the dose. As for formulations, 12 were in the form of powders and two were in tablet form for prescription drugs. For OTC drugs, 62 were formulated as powders, 13 as tablets, 48 as liquids, and four as decoctions. Many kinds of additives were used; even products by the same company included different additives, though dosage levels were often the same.[Conclusion] Kakkonto in prescription and OTC drugs had a wide range of herbal composition ratios and amounts thereof. Pharmacists should be aware of such differences and appropriately provide information to medical staffs, patients, and general consumers.論